• Review of FDA Guidance "Codevelopment of Two or More New Investigational Drugs for Use in Combination"

    14 August, 2013 Seth A. Mailhot, Special Counsel, Sheppard Mullin Richter & Hampton LLP

    On June 14, 2013, FDA issued the Guidance “Codevelopment of Two or More New Investigational Drugs for Use in Combination.” The guidance discusses FDA’s recommendations for developing an entirely new combination therapy where none of the drugs to be used in combination have been previously developed. FDA notes in the guidance that the recommendations do not apply to combination therapies involving previously developed drugs, or the combination of a new drug with a previously developed drug. While codevelopment has generally been centered in oncology and infectious disease, FDA’s guidance is intended to address codevelopment from a high-level, making it applicable to other diseases.

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  • MasterControl.Cloud

    5 September, 2013 Victor Gill, MasterControl Inc., Senior Product Manager of Cloud Solutions

    What exactly is Cloud? Or is it, The Cloud? Is it just me, or do no two people describe it the same way? As the product manager over the Cloud initiative at MasterControl, I hear these kinds of questions all of the time. With all of the advertising, mixed messaging, technical jargon, and promises of grandeur, it’s easy to see why so many consumers are confused. At its heart, the term Cloud has been a powerful marketing turn-of-phrase that has consolidated a large mix of technologies.

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  • Innovation and the Quality Process

    8 October, 2013 Ken Peterson, Director of Quality and Consultation Services, MasterControl Inc.

    Thinking of new ideas and putting those ideas to practical economic use can be more of an art than a science. At times innovation sends a signal that is in opposition to quality. If we are constantly trying to solve problems and find solutions through effective investigation of failures, do we ever consider that the best solution is to ignore the past and invent the future? Those of us who have a wider view of what innovation should deliver seek entirely new approaches verses conventional problem-solving for cause. It’s not that analytical thinking is unnecessary but on occasion, a new solution unrelated to cause removal is warranted.

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  • Developing a Winning FDA Strategy for Clinical Drug Development

    8 October, 2013 Robert L. Kunka, Ph.D., The Kunka Group, Inc.

    The idea of interacting with the FDA is sometimes mysterious and unsettling for a pharmaceutical company. The average person finds it difficult to work with a large organization that they don’t understand. For example, large banks understand this and advertise themselves as the friendly bank that works to help “their neighbors” with buying a house. The FDA’s clients are pharmaceutical companies. Unlike banks, the FDA has significant leverage over the company because it is responsible for reviewing a company’s drug with the hope that FDA will approve it. While many companies are also large, there is no real leverage that the company has over the FDA. Thus, the company is at a distinct unsettling disadvantage. However, both parties have the common desire to market safe and effective drug products. Where the rubber hits the road is that the two parties need to agree on what is needed to demonstrate that the drug is safe and effective.

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  • Avoiding the Silo Effect: The Importance of Communication in Clinical Trials

    12 November, 2013 Rebecca York, Senior Clinical Research Associate, PPD

    As clinical research professionals, we rely on the adage, “If it wasn’t documented, it wasn’t done.” This simple concept guides our every effort in creating solid, reproducible scientific progress. However, without effective communication between stakeholders in clinical trials, research sites are doomed to repeat the same (well-documented) mistakes, and study progress can be hindered, shrouded in a fog of confusion and misunderstanding. With that in mind, perhaps the time has come for an addendum: “If it wasn’t documented, it wasn’t done – but if it wasn’t communicated, it can’t be corrected!” The flow of communication, from investigative sites through monitors to clients (study sponsors) and to regulatory authorities, must be clearly defined and maintained in order to assure the success of a trial.

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  • 6 Ways to Leverage Risk-Based Monitoring & Clinical CAPA

    14 November, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    A big part of the cost of developing a new drug can be attributed to clinical research, which typically lasts at least eight-and-a-half years.  For this reason, regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are emphasizing the need to mitigate clinical-trial risks (1).

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  • A Risk-Based Approach to Validation

    10 December, 2013 Peter Knauer, Partner Consultant, MasterControl Inc.

    FDA classically has defined the requirements for validation under 21 CFR 820 and 210/211 regulations as a comprehensive testing process where all systems are given thorough examination and tested under equal weight, complete with an exhaustive evaluation process. Recent guidance and initiatives by FDA (Process Validation: General Principles and Practices) and ICH (Q11: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES) have provided a streamlined risk based approach under an updated life cycle management methodology. Under this scenario, a new definition of validation has emerged, best described by FDA as “the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process is capable of consistently delivering quality products.” This is in contrast to the classical definition as perhaps best emphasized in the device regulations under 21 CFR 820.75:

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  • Biosimilars Establishing Themselves in Europe

    12 December, 2013 Peter Calcott, President, Calcott Consulting LLC.

    From the introduction of the Guidelines for Biosimilars in the EU in 2004, Europe has been pressing hard for the introduction of these money-saving options into the marketplace.  The initial guidelines of 2004 were followed very rapidly with further guidances on comparability (2005), preclinical and clinical requirements (2005), recognition of the changing landscape (2010) and in 2011, further recommendations for studies and statement of the recognition of the issues surrounding lice

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  • An Argument for Effective Quality Management Systems

    31 December, 2013 Kamaal Anas, Vice President Regulatory Affairs, Wright Medical Technology

    All too often, quality management systems are seen as a cost of doing business – a requirement of regulators (e.g., 21 CFR 820), customers (e.g., ISO 9001:2008) or overbearing parent companies – rather than as a tool for management to effectively manage their organizations. However, quality management systems that are effectively designed, implemented, utilized and continuously improved upon provide management with quality information, delivered in a timely fashion, which facilitate data-driven decision making. Designing and implementing a quality management system that provides the appropriate information for management to make educated decisions requires careful thought and detailed planning. Once accomplished, management will have the tools to effectively allocate resources to risk-prone areas and reduce the cost of poor quality.

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  • Where Are You in Your Quality Management Maturity?

    31 January, 2014 Robyn Barnes, Public Relations Specialist, MasterControl Inc.

    We’ve all heard about quality management journeys or trips down the quality lane. I heard someone recently equate quality to following the yellow brick road. Quality similes are usually about pathways but this week, I read a new description.

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  • “3 Loops in 1” as Reflected in FDA Warning Letters

    12 February, 2014 Cindy Fazzi, Marketing Communications, MasterControl Inc.

    Anyone who keeps an eye on the FDA’s website for enforcement actions and warning letters knows that violations pertaining to corrective action and preventive action (CAPA) are among the most common issues cited by the agency (1).

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  • Responding to FDA 483s: Do’s, Don’ts, and When to Call In a Remediation Partner

    14 February, 2014 Lisa Weeks, Marketing Communications, MasterControl Inc.

    Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!

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  • Medical Device Clinical Trials – How Do They Compare with Drug Trials?

    18 February, 2014 Brandy Chittester, Director of Clinical Monitoring Services, IMARC Research, Inc.

    It seems like the clinical research world is often thought of in terms of pharmaceuticals. Clinical trials are often referred to in Phases, such as “a Phase 2 study of a new drug” or “a Phase 3 randomized clinical study with a placebo control.” Although clinical trials for medical devices have many similarities to those for pharmaceuticals, there are some necessary differences in the way the trials are designed and carried out. And in some cases, for medical devices, clinical trials may not even be required!

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  • More Helpful Quality Event Management Tips from MasterControl CAPA Presentation

    5 March, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    A previous post to this blog covered some of the highlights of a recorded MasterControl webinar that discusses best practices for corrective and preventive action (CAPA) systems. The free recording is presented by quality expert Ken Peterson, a prominent consultant who has decades of experience with risk management, customer service, and CAPA systems. Peterson has devoted his quality expertise to a long list of successful companies such as Pfizer, Abbott Laboratories, Kodak, and IBM.

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  • On the Quality of Vendor/Supplier Audit Responses

    8 April, 2014 by John Janeri, Independent CSV/Part 11 Auditor working with Polaris Compliance Consultants; Edited by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    After writing, revising, and signing the finalized audit report, most independent auditors move on to their next project.

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  • Leverage TOQ for a Faster, Cost-Effective Software Validation

    10 April, 2014 by Richard Dirkson, Senior Validation Services Consultant, MasterControl Inc.

    More and more regulated companies are using electronic quality management systems, but the concept of software validation remains a mystery to many engineers and quality professionals. In this article, I will try to shed light on the underlying goal of software validation within the context of FDA guidelines and offer a practical strategy.

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  • Conducting an Effective Failure Investigation: Going Deep Enough to Hit Root Cause

    24 April, 2014 by Christine Park, Quality Architech, Christine Park & Associates

    The FDA has increased focus on the effectiveness of failure investigations during recent inspections. A review of recent 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to really identify root cause.

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  • Ruined by Best Efforts

    22 May, 2014 by Craig Gygi, Executive Vice President, MasterControl Inc.

    When W. Edwards Deming famously said, “We are being ruined by ‘best efforts,’” he was conveying the idea that simply striving to improve—even with laudable effort—can actually have the opposite outcome. How can this be? How could good intentions and diligent work ever possibly sabotage us? Well, they do all the time.

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  • How to Cut Your Document-Approval Cycle Time Using Escalation

    27 May, 2014 by Marty Jackson, Professional Services Consultant, MasterControl Inc.

    From SOPs and procedures to CAPAs and deviations, most regulated companies maintain document-based and form-based processes for compliance and business reasons. How do you get approval for your documents and forms? How many processes do you have and how long is your approval cycle time for each one?

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  • How Can You Measure the Return on Your QMS Investment?

    29 May, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.

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